New to us, the release also notes that “other insurers” have stated they will not cover the artificial pancreas. JDRF told us that, while some major payers are covering the MiniMed 670G (Aetna, Cigna, and Humana), Anthem has issued a noncoverage decision, citing that data is “too limited.” A number of plans have yet to issue a decision.

JDRF has launched a bold advocacy campaign, titled #Coverage2Control, to “tell insurance companies to provide coverage that works for people with type 1 diabetes.” The call-to-action is a petition, which has garnered an impressive ~15,000 signatures already (the goal was actually increased from an initial 10,000 to 20,000 now). The petition calls on insurance companies to provide: (i) Affordability – keep out-of-pocket insurance costs predictable and reasonable for insulin and diabetes management tools; (ii) Choice – give people the freedom to choose the insulin pump that’s right for them; and (iii)Coverage – cover all life-saving technology, including artificial pancreas systems. Signing the petition only requires entering contact information that is confidential – with well over 1.0 million patients and multiple friends, families, caregivers able to sign, plus type 2 patients, there is lots of room for success here!

The hard-hitting press release criticizes UnitedHealthcare’s “exclusive agreement” (i.e., signed with Medtronic last year) that limits choice of insulin pumps, forcing patients to pay far higher out-of-network costs if they want to pick a different pump. The one-page infographic picks up on this theme, comparing choice of a smartphone to choice of an insulin pump – “More than frustrating,” it notes about limited pump choice, “It may be life threatening.” There are no citations provided on this front.

New to us, the announcement also notes, “Other insurers have stated they will not cover the artificial pancreas...” JDRF told us that while major payers such as Aetna, Cigna, and Humana are covering the MiniMed 670G, Anthem has issued a noncoverage decision for the system, citing that data is “too limited,” and a number of other plans are still deciding.

To keep out-of-pocket costs reasonable and consistent throughout the year, JDRF is urging insurers to offer options that could include: removing insulin and diabetes management tools from deductibles so that costs are consistent throughout the year (as health plans do for “preventive” drugs); move insulin and diabetes tools to tier 1 or tier 2 benefit levels; and provide cost-sharing as fixed dollar “co-payments” (instead of coinsurance). We like how actionable these steps are, though we’re not sure how easily plans can make these changes. For instance, we know from reimbursement experts in our network that many payers don’t even know if a beneficiary has type 1 vs. type 2 diabetes. We also don’t see a lot of support for diabetes from payers – anecdotally, diabetes seems a frustration to many.

We’ll be fascinated to see how payers respond to this campaign – presumably JDRF will collect the names at some point and send the list to major payers. We’re not sure if Medicare will be included, given the continued hiccups in getting Dexcom’s G5 CGM actually covered (see Dexcom 1Q17) following the incredible news that this was the goal (that’s the most important move from our view and marks incredible progress from JDRF and others). In a later phase of this campaign, members of the diabetes community will be able to email tailored messages to their own plan – we see this being particularly effective, particularly as the volume increases.

JDRF has an incredible track record of applying pressure to different sectors to move the needle, most memorably in taking out a full-page NYT ad to pressure FDA on the artificial pancreas guidance document – that was inspired by former CEO Jeffrey Brewer, now the CEO of notable Bigfoot Biomedical that is changing the landscape for traditional pump and CGM patients as well as a much broader audience of people with diabetes. We look forward to watching the outcomes here, including on the insulin pricing front – though devices are a big focus of this effort, insulin is mentioned several times. Ultimately, diabetes technology advances are useless unless patients can afford them, so we’re glad to see JDRF broadening its focus on access with this campaign. They do not mention pricing of pumps or CGM.

This move is part of JDRF’s 2017 Advocacy Agenda, which includes renewing the Special Diabetes Program, working with FDA on new therapies, promoting access to therapies and technologies (e.g., this program), working on outcomes beyond A1c (T1D Outcomes), and protecting preexisting conditions provisions. The full version of JDRF’s Advocacy agenda is posted here.

“JDRF strongly opposes health plan policies that limit your choice of insulin pump. We advocate for a competitive market and provide tools to help the T1D community represent their needs to health plans.” We wonder how payers might respond to this, since we imagine some might think, “All insulin pumps are the same.” Clearly this is not true from many patients’/HCPs’ perspectives (especially as automation comes on the scene), but it’s possible some payers don’t see meaningful differentiation between pumps and/or they would like more data.

Tandem has been the hardest hit by the UHC/Medtronic agreement, with sales slowing significantly in both 4Q16 (-15% YOY) and 1Q17 (-13% YOY). Could this campaign change UHC’s mind? (Insulet, notably, was excluded from the deal, since it applies to durable pumps.)

Will limited choice deals expand in diabetes technology? Will we see this in CGM, just as we have with “preferred” insulins and “preferred” strips? Will payers move to “preferred diabetes service/coaching” models as companies like Medtronic, Onduo, and others bundle glucose monitoring hardware, software/apps, and HCPs/coaches? It will be interesting to see how this evolves as the field’s business models change. For payers, exclusivity presumably offers lower costs in a field where payers want to see lower prices. On the other hand, patients can be harmed when choice is limited and the more data developed to show this, the better off patients will be.

Within “affordability,” we wonder how payers might interpret “predictable and reasonable.” Would some respond, “Wait, out-of-pocket costs are predictable and reasonable right now,” given pricing of insulin and devices? Will payers pass the buck to insulin and device manufacturers? How will they view value over time?

We also hope cost transparency becomes clearer for people with diabetes and HCPs. Many people with diabetes find it near-impossible to know what out-of-pocket costs will actually be (us included!). Often, this only clear up when the device ordering/prescription fill process has completed, or worse, the pharmacist asks you to “pay $300 for your insulin” because the formulary has changed and we don’t have a prescription (on us!) for the “new” insulin. Formularies frequently change, but patients and HCPs aren’t always updated. In addition, it’s hard to know at any given moment how far along you are in your deductible. We wish payers would make dashboards and interfaces to enable more informed out-of-pocket decisions – many patients feel this has gone downhill over time.

JDRF is now firmly using “1.25 million” Americans living with type 1 diabetes. This is lower than the ~1.5 million we frequently hear companies quote, and refreshingly lower than JDRF’s previous “up to 3 million” number. (The latter was hard to believe, so we’re glad to see the revision.) According to JDRF’s T1D facts page, “1.25 million” stems from three sources: (i) CDC’s 2014 estimate that ~5% of people with “diagnosed diabetes” in the US have type 1 (21 million x 5%) – this itself used to be often quoted as “5-10%” but as type 2 has expanded, 10% wasn’t the case anymore; (ii) Impreatore, et al. Diabetes Care 2012; and (iii) JDRF internal estimates.

It is certainly true that “my pump/my choice” is true for patients that are self-insured. Beyond patients that are self-insured, we do not expect payers to shy away from agreements that are, if not exclusive, make it very hard for patients to choose anything beyond preferred. This has been the case for some time with insulin and strips and this has been extremely upsetting to many patients and HCPs but has not changed meaningfully without HCP intervention. This is a big negative from our view since HCPs are not paid for this time. We are happy to see JDRF work to further amplify patient voice and we look forward to seeing data that backs up the value behind further patient choice.

Close Concerns Questions

Q: How will payers respond to this campaign? What kind of changes might it drive? What’s the time horizon for these changes to occur?

Q: How will UHC/Medtronic specifically respond to this campaign?

Q: What will it take for reluctant payers citing limited data to cover artificial pancreas technology, assuming they already cover pumps and CGM?